Tying knots

ABSTRACT

A suture knot can be tied during a medical procedure by use of a suture retainer ring in connection with a suturing instrument. The retainer ring allows a user to orient a suture about the instrument, such that a knot in the suture is automatically advanced and tightened by withdrawing the instrument from a surgical site after placing the suture. The retainer ring can be an integral part of the suturing instrument, or it can be removably coupled to the suturing instrument to facilitate use of the retainer ring with other suturing instruments.

TECHNICAL FIELD

The invention relates to devices and methods for tying knots.

BACKGROUND INFORMATION

Suturing of body tissue is a time consuming aspect of many surgicalprocedures. For many surgical procedures, it is necessary to make alarge opening in the human body to expose the area that requiressurgical repair. There are instruments available that allow for viewingof certain areas of the human body through a small puncture woundwithout exposing the entire body cavity. These instruments, calledendoscopes, can be used in conjunction with specialized surgicalinstruments to detect, diagnose, and repair areas of the body thatpreviously required open surgery to access.

Some surgical instruments used in endoscopic procedures are limited bythe manner in which they access the areas of the human body in need ofrepair. In particular, the instruments may not be able to access tissueor organs located deep within the body or that are in some wayobstructed. Also, many of the instruments are limited by the way theygrasp tissue, apply a suture, or recapture the needle and suture.Furthermore, many of the instruments are complicated and expensive touse due to the numerous parts and/or subassemblies required to make themfunction properly. Suturing remains a delicate and time-consuming aspectof most surgeries, including those performed endoscopically.

Another difficult and time-consuming aspect of suturing tissue is tyingthe suture into a knot. The type and placement of the knot will dependon the nature of the surgical procedure, for example, ligation,fixation, or approximation; however, regardless of the type ofprocedure, it is necessary to manipulate the ends of the suture to formthe required loop(s) to tie the knot. Further, it is subsequentlynecessary to manipulate and position the knot relative to the tissue.The manipulation and positioning of the suture and knot is difficult,because there may be limited space in which to work and limited visualaccess to the final position of the knot, in particular in anendosurgical environment.

SUMMARY OF THE INVENTION

The invention generally relates to devices and methods for simplifyingthe tying of knots during a medical procedure. Suture knots can be tiedby use of a suture retainer ring in connection with a suturinginstrument. The retainer ring allows a user to orient a suture about theinstrument, such that a suture knot is automatically advanced andtightened by withdrawing the instrument from a surgical site afterplacing the suture. The retainer ring can be an integral part of thesuturing instrument, or it can be removably coupled to the suturinginstrument to facilitate use of the retainer ring with other suturinginstruments.

In one aspect, the invention is directed to a suturing instrument. Theinstrument includes an elongate body member and a collar. The elongatebody member has a distal portion. The distal portion of the elongatebody member defines an opening. The collar is disposed about theelongate body member and defines two slits. In some embodiments, thecollar includes a body that defines an opening therethrough. The collarcan further include a protrusion disposed on the body. The body can becylindrical and the protrusion can be a ring circumferentially disposedabout the body. The ring can include a flexible material, and the slitscan be radially disposed on a circumference of the ring. In addition,the slits can extend substantially the entire length of the ring.

In other embodiments, the distal portion of the elongate body member canalso define a slot in communication with the opening in the distalportion of the elongate body member. Further, a needle catch can bedisposed on the distal portion of the elongate body member. In variousembodiments, the collar comprises a flexible material and the two slitsare disposed proximate one another to form a flexible flap. In oneembodiment, the two slits can be disposed about 180 degrees apart. Inanother embodiment, the collar can define a third slit. The third slitcan be disposed proximate one of the two slits. Further, the collar canbe slidably disposed on the elongate body member.

In another aspect, the invention relates to a suture retaining device.The device includes a body having an opening therethrough and aprotrusion disposed on the body. The protrusion defines two slits.

In various embodiments, the body can be cylindrical and the protrusioncan be a ring circumferentially disposed about the body with the slitsbeing disposed on a circumference of the ring. The ring can becircumferentially disposed about a midline of the body. The slits can beradially disposed on a circumference of the ring. The protrusion caninclude a flexible material with the two slits radially disposed andproximate one another to form a flexible flap. In one embodiment, thering can include a third slit disposed on the circumference of thecollar. The third slit can be radially disposed proximate one of the twoslits. In another embodiment, the two slits can be disposed about 180degrees apart. Further, the body can be slidably disposed on a suturinginstrument.

In another aspect, the invention relates to a method of tying a knotwith a suturing instrument. The method includes the steps of inserting aneedle and a suture attached thereto into an opening defined by a distalportion of the suturing instrument, lacing the suture through a slotdefined by the distal portion and disposed adjacent the opening on thesuturing instrument, forming a first loop with the suture, inserting thefirst loop into a slit defined by a collar disposed on a proximalportion of the suturing instrument, forming a second loop by wrappingthe suture about a protuberance disposed on the distal portion of thesuturing instrument and threading the suture through the second loop,and inserting the suture into a second slit defined by the collar. Inone embodiment, the method also includes the steps of inserting thesuturing instrument within an opening in a body, advancing the needlethrough tissue in the body and into a needle catch, and withdrawing thesuturing instrument from the body thereby pulling the first loop fromthe first radial slit and releasing the second loop from about theneedle catch.

These and other objects, along with advantages and features of thepresent invention herein disclosed, will become apparent throughreference to the following description, the accompanying drawings, andthe claims. Furthermore, it is to be understood that the features of thevarious embodiments described herein are not mutually exclusive and canexist in various combinations and permutations.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention. In the followingdescription, various embodiments of the present invention are describedwith reference to the following drawings, in which:

FIG. 1 is a schematic perspective view of an embodiment of a suturinginstrument in accordance with the invention;

FIG. 2A is a schematic plan view of a needle coupled to a suture for usein a suturing instrument in accordance with the invention;

FIG. 2B is a schematic cross-sectional view of a distal portion of thesuturing instrument of FIG. 1 with the needle in a retracted position;

FIG. 2C is a schematic cross-sectional view of the distal portion of thesuturing instrument of FIG. I with the needle in an advanced position;

FIG. 2D is a schematic perspective view of a needle catch for use withthe suturing instrument of FIG. 1;

FIG. 3A is a schematic perspective view of one embodiment of a sutureretaining device in accordance with the invention;

FIG. 3B is a schematic end view of the suture retaining device of FIG.3A;

FIG. 3C is a schematic side view of the suture retaining device of FIG.3A;

FIG. 3D is a schematic end view of an alternative embodiment of a sutureretaining device in accordance with the invention;

FIGS. 4A-4H are schematic perspective views of the suturing instrumentof FIG. 1 in use;

FIG. 5A is a schematic perspective view of an alternative suturinginstrument in accordance with the invention; and

FIG. 5B is a schematic end view of the suture retaining device of FIG.5A.

DESCRIPTION

In general, the invention relates to improvements in suturing devices,such as those disclosed in U.S. Pat. Nos. 5,364,408 and 6,043,351, eachof which is incorporated by reference herein in its entirety. Further,the invention generally relates to devices and methods for simplifyingthe tying of suture knots during a medical procedure. A device accordingto the invention can be used intracorporally to facilitate the tying ofsuture knots by incorporating a suture retainer ring onto a suturinginstrument. The suture retainer ring allows a user to orient the sutureabout the suturing instrument, such that a knot is automaticallyadvanced and tied by withdrawing the suturing instrument from a surgicalsite after placing a suture. The suturing instrument can be used forsling anchoring, closing wounds, or any medical procedure where a knotis required after a suture is placed. The suturing instrument isparticularly useful in medical applications where knotted sutures arerequired in areas of the body that are difficult to access.

Referring to FIG. 1, in one embodiment, the suturing instrument 20includes an elongate body member 22, a handle 46, an actuator 48, and asuture retaining device (or collar) 10 slidably disposed about aproximal portion 28 of the elongate body member 22. The proximal portion28 of the elongate body member 22 is mechanically coupled to the handle46. A portion of the actuator 48 is slidably disposed within the handle46 and the elongate body member 22 and a portion of the actuator 48extends out of the handle 46. A distal portion 30 of the elongate bodymember 22 includes a raised portion (or protuberance) 32 and a curvedportion 44 including a knot pusher 45. The raised portion 32 includes aneedle catch 34. The curved portion 44 defines a needle exit port 24 anda suture slot 26. The curved portion 44 also defines an opening 54 forreceiving tissue.

Referring to FIGS. 1 and 2A-2D, in one embodiment, an arcuate extendableneedle holder 58 is disposed within a channel 82 in the curved portion44. A distal portion 60 of the needle holder 58 defines a lumen 62 forholding a needle 70. In one embodiment, the needle 70 includes a tissuepenetrating tip 76 and a shaft 74 coupled to the tip 76 forming ashoulder 72 (FIG. 2A). The shaft 74 is coupled to a first end 56 of asuture 40. The needle 70 is inserted into the lumen 62 and held by aslight friction fit. The suture 40 extends out of the suture slot 26.

In operation, a user pushes the actuator 48 which, in turn, pushes aspring-loaded rod 80, which pushes the needle holder 58 out of theneedle exit port 24. The user continues to push the actuator 48 untilthe needle 70 enters the needle catch 34. The needle catch 34, as shownin FIG. 2D, includes openings 78 defined by successive ribs 79. Theneedle catch 34 receives the needle 70 (coupled to the suture 40)through opening 78, the ribs 79 deflect slightly to allow the needle 70to pass through. After the formed shoulder 72 has passed the ribs 79 andthe needle holder 58 has been withdrawn (by releasing the actuator 48),thereby releasing the needle 70, the ribs 79 spring back to theiroriginal position defining the openings 78. The openings 78 are chosento be smaller in dimension than the formed shoulder 72. This causes theneedle catch 34 to retain the needle 70, because, due to the flat rearsurface of the shoulder 72, the needle 70 cannot pass back through theopening 78. When it is necessary to remove the needle 70 from the needlecatch 34, the needle 70 may be removed via an enlarged portion 77 of theopening 78. The enlarged portion 77 is sized to allow the formedshoulder 72 to pass through without resistance. The needle catch 34 ispreferably constructed of thin stainless steel of high temper, such asANSI 301 full hard. The needle catch 34 may be fabricated by means ofstamping, laser machining, or chemical etching.

Referring to FIGS. 3A-3C, in one embodiment, the suture retaining device10 includes a cylindrical body portion 12 that defines a body opening 16extending therethrough. The suture retaining device 10 further includesa protrusion 14 coupled to an outer surface 17 of the body portion 12.In the embodiment shown, the protrusion 14 is a ring circumferentiallydisposed about the body 12. The ring 14 is coaxial with the body portion12 and defines a first slit 18 a and a second slit 18 b. The slits 18 a,18 b are radially disposed approximately 180 degrees apart on the ring14 and extend through the length 12 of the ring 14 in a directionparallel to the axis of the body portion 12 and the ring 14.Alternatively, the slits 18 a, 18 b could extend non-radially and/or notextend completely through the ring 14. The elongate body member 22(FIG. 1) extends through the body opening 16, such that the sutureretaining device 10 is manually slidable along the elongate body member22. The position of the suture retaining device 10 along the elongatebody member 22 is maintained through a friction fit. In an alternativeembodiment (FIG. 3D), the body portion 12 and the ring 14 can define agap 21. The gap 21 can be enlarged to allow the suture retaining device10 to be clipped onto the elongate body member 22.

In various embodiments of the suture retaining device 10, the insidediameter D₁ of the body portion 12 is about 0.15 to 0.60 inches andpreferably about 0.4 inches, the outside diameter D₂ of the body portion12 is about 0.25 to 0.75 inches and preferably about 0.5 inches, and theoutside diameter D₃ of the ring 14 is about 0.75 to 1.5 inches andpreferably about 1.1 inches. The length 11 of the body portion 12 isabout 0.5 to 1.0 inches and preferably about 0.7 inches, and the length12 of the ring 14 is about 0.06 to 0.18 inches and preferably about 0.13inches. In alternative embodiments, the body portion 12 can be of ashape other than cylindrical, such as elliptical or rectangular, forexample. The shape and material chosen for the suture retaining device10 will vary to suit a particular application. In still otherembodiments, the ring 14 can be replaced by one or more than oneprotrusion(s) disposed on the body portion 12.

The suturing instrument's component materials should be biocompatible.For example, the handle 46, the elongate body member 22, the sutureretaining device 10, and portions of the actuator 48 may be fabricatedfrom extruded, molded, or machined plastic material(s), such aspolypropylene, polycarbonate, glass-filled polycarbonate, or othermedical grade plastic. Other components, for example the needle 70, maybe made of stainless steel. Other suitable materials will be apparent tothose skilled in the art. The type of material(s) used to form thesuture 40 is not critical to the present invention, as long as thematerial is biocompatible. The surgeon will select the length, diameter,and characteristics of the suture to suit a particular application.

Referring to FIG. 4A, an initial configuration of the suturinginstrument 20 includes loading the suturing instrument 20 with a needle70 and a suture 40. A user (e.g., physician or other medical personnel)pushes the actuator 48 in a direction indicated by arrow 64, therebycausing the needle holder 58 to extend out of the needle exit port 24.The user next inserts a needle 70 coupled to a first end 56 of thesuture 40 into the lumen 62 (FIGS. 2B and 2C). After the needle 70 isloaded, the actuator 48 is released, which allows the needle holder 58to retract into the curved portion 44. The user then runs the suture 40through the suture slot 26 and extends the suture 40 along the elongatebody member 22. The user then inserts the suture 40 into slit 18 b andfolds the suture 40 back 180 degrees and again inserts the suture 40into slit 18 b thereby creating a first loop 36. The user then looselyties the suture 40 in a knot 38 forming a second loop 42. The userplaces the second loop 42 over the raised portion 32. The user thenextends the suture 40 back along the elongate body member 22 and insertsa second end 66 into slit 18 a. In this initial configuration, thesuture 40 is slack and approximately twice as long as the length of thesuturing instrument 20 that is to be inserted into a patient.

Referring to FIGS. 4A-4C, in operation, the user inserts the elongatebody member 22 into a patient and orients the elongate body member 22 sothat the needle exit port 24 is in contact with the tissue 50 to besutured. The user then pushes the actuator 48 in the direction indicatedby arrow 64. Pushing the actuator causes the needle holder 58 (holdingthe needle 70) to extend out of the needle exit port 24 and push theneedle 70 through the tissue 50. As the needle 70 is pushed through thetissue 50, the needle 70 pulls the suture 40 through the tissue 50. Asthe user continues to push the actuator 48, the needle holder 58continues to advance out of the needle exit port 24 and directs theneedle 70 and the suture 40 toward the needle catch 34. The usercontinues to push the actuator 48 until the needle 70 contacts andbecomes captured by the needle catch 34 (FIG. 4C).

Referring to FIGS. 4D-4G, after the user retracts the needle holder 58by releasing or pulling the actuator 48, the needle 70 and the suture 40are left captured within the needle catch 34, with the suture 40extending through the tissue 50. The user then pulls the suturinginstrument 20 away from the tissue 50 (FIG. 4D). The first loop 36 ispulled out of slit 18 b and the second loop 42 is subsequently pulledoff the raised portion 32 and over the first end 56 of the suture 40(FIG. 4E). As the user continues to pull the suturing instrument 20 awayfrom the tissue 50, the first end 56 of the suture 40 is pulled throughthe second loop 42. The second loop 42 gradually closes and the knot 38gradually tightens around the first end 56 of the suture 40 (FIG. 4F).Eventually, the knot 38 securely tightens around the suture 40 and isflush with the tissue 50 (FIG. 4G).

Referring to FIG. 4H, the user pushes the knot pusher 45 against theknot 38. The user then removes the second end 66 of the suture from slit18 a and pulls the second end 66 of the suture 40 in a direction awayfrom the tissue 50. This optional procedure serves to further tightenthe knot 38 and secure the suture 40 against the tissue 50.

In operation, the length of the suture 40 can be controlled by manuallysliding the suture retaining device 10 along the elongate body member22. For example, for a long suture 40, the user manually slides thesuture retaining device 10 towards the proximal portion 28 of theelongate body member 22. For a short suture 40, the user manually slidesthe suture retaining device 10 towards the distal portion 30 of theelongate body member 22.

Referring to FIG. 5A, in an alternative embodiment, the suturinginstrument 83 includes an elongate body member 22, a handle 46, anactuator 48, and a suture retaining device (or collar) 11 slidablydisposed about the approximate midpoint of the elongated body member 22.A proximal portion 28 of the elongate body member 22 is mechanicallycoupled to the handle 46. A portion of the actuator 48 is slidablydisposed within the handle 46 and the elongate body member 22 and aportion of the actuator 48 extends out of the handle 46. A distalportion 30 of the elongate body member 22 includes a raised portion 32and a curved portion 44 that includes a knot pusher 45. The raisedportion 32 includes a needle catch 34. The curved portion 44 defines aneedle exit port 24 and a suture slot 26. The curved portion 44 alsodefines an opening 54 for receiving tissue.

Referring to FIG. 5B, the alternative suture retaining device 11includes a cylindrical body portion 13 that defines a body opening 19extending therethrough. The suture retaining device 11 further includesa ring 15 coupled to an outer surface of the body portion 13. The ring13 is coaxial with the body portion 13 and defines a first slit 88 a, asecond slit 88 b, and a third slit 88 c. Slits 88 b, 88 c are radiallydisposed on the ring 13 proximate one another and about 180 degrees fromradially disposed slit 88 a. The slits 88 a, 88 b, 88 c extend throughthe length of the ring 13 in a direction parallel to the axis of thebody portion 13 and the ring 15. Alternatively, the slits 88 a, 88 b, 88c could extend non-radially and/or not extend completely through thering 13. A flexible flap 90 separates slits 88 b and 88 c. The elongatebody member 22 extends through the body opening 19, such that the sutureretaining device 11 is slidable along the elongate body member 22. Theposition of the suture retaining device 11 along the elongate. bodymember 22 is maintained through a friction fit. The materials used tomake this alternative embodiment are similar to those previouslydescribed.

Referring again to FIG. 5A, an initial configuration of the suturinginstrument 83 includes loading the suturing instrument 83 with a needle70 and a suture 40. A user pushes the actuator 48 in a directionindicated by arrow 64, thereby causing the needle holder 58 to extendout of the needle exit port 24. The user next inserts a needle 70coupled to a first end 56 of the suture 40 into the lumen 62 (FIGS. 2Band 2C). After the needle 70 is loaded, the actuator 48 is released,which allows the needle holder 58 to retract into the curved portion 44.The user then runs the suture 40 through the suture slot 26 and extendsthe suture 40 along the elongate body member 22. The user then insertsthe suture 40 into slit 88 b and folds the suture 40 back 180 degreesand inserts the suture 40 into slit 88 c. The user then loosely ties thesuture 40 in a knot 38 creating a loop 92. The user places the loop 92over the raised portion 32. The user then extends the suture 40 backalong the elongate body member 22 and inserts the second end 66 intoslit 88 a. In this initial configuration, the suture 40 is slack andapproximately twice as long as the length of the suturing instrument 83that is to be inserted into the patient. The suturing instrument 83operates largely in the same manner as the suturing instrument 20previously described. However, instead of a loop sliding out of a singleslit when the suturing instrument 83 is pulled away from the tissue 50,tension in the suture 40 causes the flexible flap 90 to bend allowingthe suture 40 to slip off the flexible flap 90 and out of slits 88 b and88 c.

Variations, modifications, and other implementations of what isdescribed herein may occur to those of ordinary skill in the art withoutdeparting from the spirit and scope of the invention. Accordingly, theinvention is not to be defined only by the preceding illustrativedescription.

1-25. (canceled)
 26. A suturing instrument, comprising: an elongate bodymember including a distal portion, the distal portion including a curvedportion, the curved portion defining a channel for receiving a needle;and a collar disposed about the elongate body member and defining atleast two slits.
 27. The suturing instrument of claim 26 wherein thecollar comprises: a body defining an opening within which the elongatebody member is disposed; and a protrusion disposed on the body.
 28. Thesuturing instrument of claim 27 wherein the body is cylindrical.
 29. Thesuturing instrument of claim 27 wherein the protrusion comprises a ringcircumferentially disposed about the body.
 30. The suturing instrumentof claim 29 wherein the ring defines the at least two slits.
 31. Thesuturing instrument of claim 29 wherein the ring comprises a flexiblematerial.
 32. The suturing instrument of claim 30 wherein the at leasttwo slits are disposed proximate one another to form a flexible flap.33. The suturing instrument of claim 30 wherein the at least two slitsare disposed about 180 degrees apart.
 34. The suturing instrument ofclaim 26 further comprising a needle catch disposed on the distalportion of the elongate body member.
 35. The suturing instrument ofclaim 26 wherein the collar further defines a third slit.
 36. Thesuturing instrument of claim 35 wherein the third slit is disposedproximate one of the at least two slits.
 37. The suturing instrument ofclaim 26 wherein the collar is slidably disposed on the elongate bodymember.
 38. A suture retaining device, comprising: a cylindrical body;and a protrusion circumferentially disposed on the body and defining atleast two slits.
 39. The suture retaining device of claim 38 wherein theprotrusion comprises a ring circumferentially disposed about the bodyand defining the at least two slits.
 40. The suture retaining device ofclaim 38 wherein the protrusion comprises a flexible material.
 41. Thesuture retaining device of claim 39 wherein the at least two slits aredisposed about 180 degrees apart.
 42. The suture retaining device ofclaim 39 wherein the ring further defines a third slit.
 43. The sutureretaining device of claim 38 wherein the body is adapted to be slidablydisposed on a suturing instrument.
 44. A suture retaining device,comprising: a body defining an opening through the body; and a ringcircumferentially disposed about the body and defining two slitsdisposed proximate one another to form a flexible flap, the ringcomprising a flexible material.
 45. The suture retaining device of claim44 wherein the body is cylindrical.
 46. The suturing retaining device ofclaim 44 wherein the ring further defines a third slit.
 47. The suturingretaining device of claim 46 wherein the third slit is disposed about180 degrees from the two slits.
 48. The suture retaining device of claim44 wherein the body is adapted to be slidably disposed on a suturinginstrument.